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news.Shire has revealed additional data from the studies evaluating Resolor (prucalopride), which demonstrated acceleration of colonic transit time associated with improved bowel function in women with chronic constipation.
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Resolor is a selective, high-affinity 5-HT4 receptor agonist specifically developed to target impaired motility associated with chronic constipation.
Three Phase II dose-finding trials of 280 predominantly female patients with a mean age of 52.5 years demonstrated that compared to baseline, colon transit time significantly decreased by an average of 12 hours in patients receiving 2 mg prucalopride compared with essentially no change in patients receiving placebo.
According to another three identically designed Phase III, double-blind, placebo-controlled trials for up to 12 weeks in 458 women suffering from chronic constipation, prucalopride (2 mg) was well tolerated and improved bowel function, measured by the number of bowel movements per week; and bowel symptoms, measured by the validated Patients Assessment of Constipation Symptom questionnaire (PAC-SYM).
Shire Research and Development vice president Lieve Vandeplassche said these results highlight how prucalopride is an effective option for clinicians managing women whose chronic constipation is not adequately relieved with laxatives.
Shire Pharmaceuticals Ireland launched Resolor in Ireland on 3 May this year.
Resolor is also currently available in Germany, the UK and Belgium, and will be introduced in other countries in Europe in 2011 and 2012.